TABLE 4.
Comparison of measured PK values following oral administration of 1 mg varenicline in Chinese and simulated PK values in 300 Chinese virtual subjects.
| Parameter | Simulated value | Parameter | Measured value | ||||
|---|---|---|---|---|---|---|---|
| Mean | Standard error | Coefficient of variation (%) | Mean | Standard error | Coefficient of variation (%) | ||
| Cmax (ng/ml) | 4.59 | 1.47 | 32.06 | Cmax (ng/ml) | 4.95 | 0.69 | 14.00 |
| AUC0-t (h*ng/mL) | 88.73 | 30.14 | 33.97 | AUC0-t (h*ng/ml) | 87.31 | 19.85 | 23.00 |
| AUC0-∞ (h*ng/mL) | 93.55 | 35.68 | 38.14 | AUC0-∞ (h*ng/ml) | 91.36 | 21.23 | 23.00 |
| T1/2 (h) | 13.07 | 7.07 | 54.14 | T1/2 (h) | 15.23 | 3.38 | 22.00 |
| Median | Minimum | Maximum | Median | Minimum | Maximum | ||
| Tmax (h) | 3.00 | 2.00 | 4.00 | Tmax (h) | 3.00 | 0.50 | 6.00 |
Cmax, maximum concentration; AUC0-t, area under the plasma concentration vs. time curve from the start of the last dose to the last time at which there is a quantifiable concentration; AUC0-∞, AUC0-t extrapolated to infinity; T1/2, apparent terminal elimination half-life, Tmax, time to Cmax.